[Federal Register: June 26, 2007 (Volume 72, Number 122)]
[Notices]
[Page 35056-35057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn07-42]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
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SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of Federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
A Novel Discriminatory Small Peptide Inhibitor of Hsp90 Targeting
Oncogenic Kinases
Description of Technology: Heat shock protein 90 (Hsp90) is a
molecular chaperone required for stability and function for many
proteins (clients). Presently, there are clinical trials focusing on
small molecule Hsp90 inhibitors; however, pharmacologic Hsp90
inhibition causes destabilization, ubiquitination and proteasome-
degradation of all client proteins indiscriminately.
Hsp90 was found to be overexpressed in tumor cells; thereby making
Hsp90 a promising molecular target for cancer therapy. Additionally,
some Hsp90-dependent client proteins (non-kinases) were identified as
putative tumor suppressors, suggesting that indiscriminate degradation
of all Hsp90 client proteins is not ideal. Finding a molecular
inhibitor that discriminately inhibits Hsp90 that would target only
client kinase proteins would be an ideal therapeutic agent for cancer
treatment.
The current invention is a short peptide that inhibits Hsp90 that
prevents the recognition and function of client kinase proteins, and
promotes the degradation of client kinase proteins, while not affecting
other non-kinase client proteins.
Applications and Modality: Current applications include targeting
client kinase proteins promoting degradation, and preventing
recognition and function of the client kinase proteins; restriction of
Hsp90 inhibition to client kinases that utilize similar Hsp90
recognition sequences to the oncogenic tyrosine kinase Hsp90 client
ErbB2; and having kinase-specific chaperone inhibitors preferentially
active as anti-cancer agents compared to indiscriminate pharmacologic
inhibitors of Hsp90.
Market: 600,000 deaths from cancer related diseases were estimated
in 2006; In 2006, cancer drug sales were estimated to be $25 billion;
There is a burgeoning drug market for Hsp90 inhibitors for cancer
treatment.
Development Status: The technology is currently in the preclinical
stage of development.
Inventors: Leonard M. Neckers et al. (NCI).
Patent Status: U.S. Provisional Application No. 60/895,313 filed 16
Mar 2007 (HHS Reference No. E-121-2007/0-US-01); U.S. Provisional
Application No. 60/909,834 filed 03 Apr 2007 (HHS Reference No. E-121-
2007/1-US-01).
Licensing Status: Available for exclusive and non-exclusive
licensing.
Licensing Contact: Adaku Nwachukwu, J.D.; 301-435-5560;
madua@mail.nih.gov.
Collaborative Research Opportunity: The NCI Urologic Oncology
Branch is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize peptide inhibitor of Hsp90. Please contact John D. Hewes,
Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.
A Novel Treatment for Non-Small Cell Lung Cancer Using Mesothelin-
Targeted Immunotoxins
Description of Technology: Mesothelin is a glycoprotein, whose
expression has been largely restricted to mesothelial cells in normal
tissues, although epithelial cells of the trachea, tonsil, fallopian
tube, and kidney have shown immunoreactivity. Mesothelin has been shown
to be expressed in several cancers including pancreatic carcinomas,
gastric carcinomas and
[[Page 35057]]
ovarian carcinomas, and has the potential of being used as a tumor
marker and a novel target for the development of new treatments.
The technology relates to the finding that some non-small cell lung
cancers (NSCLC) express the antigen mesothelin. Targeting the tumors
with antibodies or immunotoxins that specifically bind mesothelin can
be a potential new treatment for non-small cell lung cancer. The SSIP
immunotoxin and its variants that specifically bind to mesothelin can
be used for the treatment of NSCLC.
Applications and Modality: NSCLC can be treated by targeting
mesothelin.
Advantage: Anti-mesothelin antibodies and immunotoxins are already
available and being tested for several cancers.
Development Status: The technology is in pre-clinical stage of
development.
Inventors: Ira H. Pastan (NCI) et al.
Patent Status: U.S. Provisional Application No. 60/891,923 filed 27
Feb 2007 (HHS Reference No. E-120-2007/0-US-01), entitled ``Treatment
of Non-Small Cell Lung Cancer with Mesothelin-Targeted Immunotoxins.''
Licensing Status: Available for exclusive and non-exclusive
licensing.
Licensing Contact: Jesse S. Kindra, J.D.; 301-435-5559;
kindraj@mail.nih.gov
Collaborative Research Opportunity: The National Cancer Institute's
Laboratory of Molecular Biology is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize anti-mesothelin antibodies and
immunotoxins. Please contact John D. Hewes, Ph.D. at 301-435-3121 or
hewesj@mail.nih.gov for more information.
A Gene Expression Profile That Predicts Ovarian Cancer Patient Response
to Chemotherapy
Description of Technology: Ovarian cancer is a poor prognosis
disease that remains the most lethal of all gynecologic malignancies.
Warning symptoms do not occur until the tumor has already spread beyond
the ovary, resulting in diagnosis at an advanced stage. As a result,
there is a poor patient prognosis with only fifteen percent of women
possessing advanced stage disease surviving for five years. Despite an
initial clinical response of 80% to surgery and chemotherapy, most
patients experience tumor recurrence within two years of treatment. The
overwhelming majority of these patients will eventually develop
chemoresistant disease and die.
Available for licensing are two gene signatures. One gene signature
can predict whether a patient will initially respond to standard
platinum-paclitaxel chemotherapy, but will relapse within six months of
completing treatment. A second gene signature identifies patients who
will show no response to therapy. This methodology may enable
clinicians to identify patients who may be candidates for additional
and/or novel chemotherapy drugs, and effectively choose appropriate
cancer treatment. A unique feature of this signature is its derivation
from pure, microdissected isolates of ovarian tumor cells, rather than
undissected tissue. By utilizing this approach, the resulting gene list
is specific to the cell type that causes the disease.
Applications: Method to detect if an ovarian cancer patient is
sensitive to treatment with chemotherapeutic agents; Method to evaluate
ovarian cancer patient chemoresponsiveness; Diagnostic tool to aid
clinicians in determining appropriate cancer treatment; Methods to
treat ovarian cancer identified by chemoresistant biomarkers
compositions.
Market: Ovarian cancer is the fourth most common form of cancer in
the U.S.; Ovarian cancer is three times more lethal than breast cancer;
15,310 deaths in the U.S. in 2006.
Development Status: The technology is currently in the pre-clinical
stage of development.
Inventors: Michael J. Birrer (NCI) et al.
Publication: SC Mok et al. Biomarker discovery in epithelial
ovarian cancer by genomic approaches. Adv Cancer Res. 2007;96:1-22.
Patent Status: U.S. Provisional Application No. 60/899,942 filed 06
Feb. 2007 (HHS Reference No. E-060-2007/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Jennifer Wong; 301/435-4633;
wongje@mail.nih.gov.
Potent, Easy to Use Targeted Toxins as Anti-Tumor Agents
Description of Technology: The invention discloses synthesis and
use of novel derivatives of 2-[2'-(2-aminoethyl)-2-methyl-ethyl]-1,2-
dihydro-6-methoxy-3H-dibenz-[de,h]isoquinoline-1,3-dione as targeted
anti-tumor agents. The use of targeted toxin conjugates with anti-
cancer antibodies, such as herceptin, is increasing. Based on a
comparison with the structurally complex toxins, such as DM1, available
in the market, these novel toxins are more stable in circulation, thus
making the toxin-conjugates more tumor-selective and less toxic. As
such, these compounds are superior alternatives to the existing toxins.
The invention describes a potent and easy to synthesize toxin that
can be used for generating a variety of prodrugs. These compounds can
be attached to a ligand that recognizes a receptor on cancer cells, or
to a peptide that is cleaved by tumor-specific proteases. The compounds
are topoisomerase inhibitors and are mechanistically different from DM1
that targets tubulin.
The structure of the toxin allows it to be modified with a peptide
linker that is stable, but rapidly cleaved in lysosomes after the
compound is specifically taken up by cancer cells.
Applications: The compounds can be used for preparation of a
variety of potent anti-cancer agents with low systemic toxicity.
Advantages: Easy to prepare; Structural features make these
compounds more stable in circulation; Toxin conjugates are more tumor-
selective and less toxic.
Benefits: 600,000 cancer deaths occurred in 2006 in spite of
advances in cancer therapeutics. A major limitation of current
therapeutics is their toxic side effects. This technology can
effectively treat cancer with low systemic toxicity and thus improve
overall survival and quality of life of patients suffering from cancer.
The current cancer chemotherapeutic market is valued at $42 billion and
expected to grow.
Inventors: Nadya I. Tarasova, Marcin D. Dyba, Christopher J.
Michejda (NCI).
Development Status: In vitro studies are completed and in vivo
animal model studies are ongoing.
Patent Status: U.S. Provisional Application No. 60/844,027 filed 12
Sep. 2006 (HHS Reference No. E-160-2006/0-US-01).
Licensing Contact: Mojdeh Bahar, J.D.; 301/435-2950;
baharm@mail.nih.gov.
Dated: June 19, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E7-12337 Filed 6-25-07; 8:45 am]
BILLING CODE 4140-01-P